ID

24801

Descripción

Study ID: 101468/228 Clinical Study ID: 101468/228 Study Title:A two year Phase IIIb randomised, multicenter, double-blind, SINEMET controlled, parallel group, flexible dose study, to assess the effectiveness of controlled release ropinirole add-on therapy to L-dopa at increasing the time to onset of dyskinesia in Parkinson's disease subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00363727 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication : Dyskinesias; Parkinson Disease; Parkinson's Disease Study part: Non-serious adverse events

Palabras clave

Versiones (4)
  1. 12/8/17 12/8/17 -
  2. 12/8/17 12/8/17 -
  3. 18/8/17 18/8/17 -
  4. 8/9/17 8/9/17 -
Titular de derechos de autor

GlaxoSmithKline

Subido en

18 de agosto de 2017

DOI

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Licencia

Creative Commons BY-NC 3.0
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Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

Inglés

Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 formularios  
General information
Descripción

General information

Protocol indentifier
Descripción

Protocol indentifier

Tipo de datos

text

Subject Identifier
Descripción

Subject Identifier

Tipo de datos

text

Alias
UMLS CUI [1]
C2348585
Visit date
Descripción

Visit date

Tipo de datos

date

Visit Description
Descripción

Visit Description

Tipo de datos

text

Non-serious adverse events
Descripción

Non-serious adverse events

Did the subject experience any non-serious adverse events during the study?
Descripción

If Yes, record details below. Note: If this is a Serious Adverse Event (SAE), do not complete this form, go to the SAE section and complete the SAE form.

Tipo de datos

boolean

Event
Descripción

Diagnosis Only (if known). Otherwise Sign/Symptom

Tipo de datos

text

Start date
Descripción

Start date

Tipo de datos

date

Outcome
Descripción

Outcome

Tipo de datos

integer

End Date
Descripción

End Date

Tipo de datos

date

Maximum Intensity
Descripción

Maximum Intensity

Tipo de datos

text

Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
Descripción

Action Taken

Tipo de datos

text

Did the subject withdraw from study as a result of this AE?
Descripción

withdrawal

Tipo de datos

boolean

Is there a reasonable possibility that the AE may have been caused by the investigational product?
Descripción

AE caused by the investigational product

Tipo de datos

boolean

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Similar models

Non-serious adverse events GSK study Dyskinesia in Parkinson's disease NCT00363727

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
General information
Protocol indentifier
Item
Protocol indentifier
text
Subject Identifier
Item
Subject Identifier
text
C2348585 (UMLS CUI [1])
Visit date
Item
Visit date
date
Visit Description
Item
Visit Description
text
Item Group
Non-serious adverse events
non-serious adverse events
Item
Did the subject experience any non-serious adverse events during the study?
boolean
Event
Item
Event
text
Start date
Item
Start date
date
Item
Outcome
integer
Outcome
Code List
Outcome
CL Item
Recovered/Resolved (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved withsequelae (4)
End Date
Item
End Date
date
Item
Maximum Intensity
text
Maximum Intensity
Code List
Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
text
Action Taken
Code List
Action Taken with Investigational Product(s) as a Result of the Non-Serious AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
withdrawal
Item
Did the subject withdraw from study as a result of this AE?
boolean
AE caused by the investigational product
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product?
boolean
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